Quality Control New Product Introduction Specialist

Quality Control New Product Introduction Specialist

Job Purpose

• Lead the qualification/validation and transfer of QC analytical test methods supporting the introduction of new products to the site.

• Co-ordinate the introduction of testing capability for new products within the Quality Control Department.

• Project management of all quality control activities required for the introduction of new products to the site.

• Support regulatory submissions of new products by co-ordinating and contributing to content reviews and data verification of CTD leaflets where the Quality Control department has an ownership stake.

• Report to internal and external stakeholders including site project management NPI leads senior management contract sites and other Pfizer sites as required.

• Partner with and build collaborations with key stakeholders across the business (e.g. ARD) to provide oversight and input across a portfolio of products.

Quality Control New Product Introduction Lead

Quality Control New Product Introduction Specialist

Job Responsibilities:

• Project management of the introduction of testing capability for new products within Quality Control inclusive of raw materials biological microbiological and chemical in-process and release testing for drug substance and drug products.

• Report project updates to the QC manager and site/network project/product leads.

• Liaise with all internal and external stakeholders inclusive of QC Laboratories QA Stability R&D Manufacturing Operations and Tech Services Supply Chain Regulatory CMOs as appropriate.

• Lead all activities involved in the verification qualification validation and transfer (as appropriate) of test methods associated with new products according to ICH guidelines.

• Represent QC NPI interests on Analytical Oversight QC siting and other network forums/product teams.

• Write/review and approve analytical gap assessments protocols and reports for validation/transfer activities.

• Author/review/approve and resolve validation and transfer deviations.

• Support statistical approaches to setting acceptance criteria for validation/transfer.

• Assist in the preparation and review of area documentation e.g. SOPs Forms sampling and analysis plans product specifications etc.

• Work with EHS to co-ordinate and complete chemical approvals and safety risk assessments associated with new materials and methods for new product testing activities.

• Troubleshoot laboratory methods and instrument problems.

• Provide routine analytical and technical support to contract test labs as part of method transfer activities.

• Facilitate training of analysts on new technologies.

• Perform and assist in additional duties as directed by the QC Manager.

• Support Laboratory inspections and audits.

• Support Annual Product Quality Reviews for validation of test methods.

• Identify and drive opportunities for Continuous Improvement via IMEX processes and embrace Pfizers culture to own and drive any activities associated with delivering these improvements.

About You

To be successful in this role you will require:

Minimum BSc Degree and 5 years experience in a Biopharmaceutical or Pharmaceutical cGMP-manufacturing environment required or equivalent.

Project management qualification is desirable.

Previous experience in a method transfer role is desirable.

Experience with regulatory submissions and query responses is desirable.

Experience in managing multiple projects and reporting regularly to management and senior management within the organisation.

Ability to communicate technical and schedule risks and required resolutions in a positive and proactive manner.

Experience with technical elements of the analytical method validation and transfer process.

Expertise and technical competence in GMP bioanalytical testing and instrumentation theory and practice (e.g. HPLC GC CE Spectroscopy cell-based methods biological/antibody-based methods and others).

Familiarity with pharmacopoeias.

Experience with Lab systems is an advantage. (LIMS Empower etc)

Proven ability to recognise problems with equipment methods software procedures and resolve the issues.

Demonstrated ability to successfully collaborate influence and lead in a matrix organization.

Excellent communication and interpersonal skills.

Proven record in demonstrating agility and resilience

Proven experience in representing your function on a network team.

Flexibility to travel in support of the role.

Proven success in proactive project management.

Proven ability to communicate problems and required resolution in a positive and proactive manner.

Self-directed self-motivated with a demonstrated record in project accountability